Senior Documentation Systems Specialist

BioSpace; Charlottesville (VA); On-site; USD 34,000 - 48,000; Full time

Job summary

Afton Scientific is seeking an experienced Documentation Systems Specialist III to join its Quality Assurance team in Virginia. The role focuses on administering and controlling master documents and related databases to ensure accuracy, traceability, and compliance with cGMP regulations.

Responsibilities include managing SOPs, batch records, and specifications; coordinating change controls and validation documentation; and supporting audits and inspections while maintaining professional

Qualifications

• Bachelor's degree or 5+ years of experience in pharmaceutical administration or documentation.
• GMP knowledge with FDA/EU guidance related to aseptic processing.
• Experience using GMP-compliant document management systems (MasterControl, Veeva, or equivalents).

Responsibilities

• Administer and control master documents and databases.
• Maintain approved controlled documents (SOPs, directives, batch records, specs).
• Notify stakeholders of changes to controlled documents and maintain change records.
• Review and approve ODRs and Change Control documentation as applicable.
• Support audits and regulatory visits by facilitating documentation requests.
• Provide general administrative support to QA and related functions.

Skills

Attention to Detail

Documentation Skills

Regulatory Compliance

Organization & Prioritization

Communication & Collaboration

Independent Problem Solving

Education

Bachelor's degree or 5+ years experience

Tools

MasterControl

Veeva

Job description

Afton Scientific is seeking an experienced Documentation Systems Specialist III to join its Quality Assurance team in Virginia. The role focuses on administering and controlling master documents and related databases to ensure accuracy, traceability, and compliance with cGMP regulations.

Responsibilities include managing SOPs, batch records, and specifications; coordinating change controls and validation documentation; and supporting audits and inspections while maintaining professional